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In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.

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Multilayer tablets: A piece of cake or just a passing fad? We bring experts together to find out.

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The authors focus on the effects of cellulosic materials during the performance qualification validation of a transfer barrier isolator used for the purpose of sterility testing.

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The aim of this study was to validate the automated clean-in-place (CIP) system installed on a capsule filling machine to determine its ability to adequately eliminate contaminants. The results obtained from the proposed cleaning validation trial showed that all the soluble tracer was removed after the washing procedure. At the end of the CIP procedure, the discharged water had the same pH, phosphate content and total organic content as the supplied water. Lack of cross-contamination in the product was also demonstrated and a recovery trial highlighted the complete elimination of the tracer from the machine.

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The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.

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San Francisco and Boston sit on opposite coasts and each has a rich history and character that make them distinct. However, they share some similarities: both cities are centers of top biotechnology hubs in the US.

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Storage and retrieval methods and the unique requirements found in building codes are crucial considerations.

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The authors discuss various approaches and related issues, including production of difficult-to express proteins using cell-free expression systems, scalability of protein expression, and site-specific chemical modifications.

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The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

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This article outlines the key concepts that define process analytical technology and emphasizes the relevant theory and applications of chemometrics.

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IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.

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Multilayer tablets: A piece of cake or just a passing fad? We bring experts together to find out.

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USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.

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This article looks at some of the current and emerging standards that are shaping the life sciences industry, and how pharma and biotech companies can benefit by implementing them.

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PDA is the leading global provider of science, technology, regulatory information, and education for the bio/pharmaceutical community.

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Adjusting the tablet press and its systems can prevent manufacturing and product quality problems.

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USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.

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This article describes the approach used to upgrade a chromatography data system. The upgrade was required to meet the current regulatory requirements for good laboratory and good manufacturing practice. Compliance with 21 CFR Part 11 for electronic records and electronic signatures was also a major consideration. The procedures used for this project followed the software development life cycle (SDLC) and involved the co-ordination of personnel from the software vendor, the user department, information technology and quality assurance.

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The global supply chain for bovine and porcine heparin and regulatory considerations are examined.

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The authors developed a metronidazole-based floating drug-delivery system to investigate the effect of rate-controlling polymers on release pattern and duration of buoyancy in matrix tablets.

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Determining whether a data point is an "outlier" - a result that does not fit, is too high or too low, is extreme or discordant - is difficult when using small data sets, such as the data from three, four or five conformance runs. In this article, the authors demonstrate that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.

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Fixed-dose combinations (FDCs) reduce the number of pills that must be taken, but they have also been a topic of concern, mainly because of the perceived potential for increased adverse events. PTE speaks with researchers to explore the benefits and concerns of FDCs.

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IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.

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In this article, the authors demonstrate that a normal-phase chromatographic method was stability-indicating for a water-sensitive prodrug. The stress conditions using aqueous and non-aqueous conditions were also compared to understand the information obtained with each approach.

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Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.

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Application of single-use technology in a parenteral facility for syringe filling.

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Applications of ZFN technology in biopharmaceutical cell-line engineering.

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A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.